UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006823
Receipt number R000008068
Scientific Title Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Date of disclosure of the study information 2011/12/03
Last modified on 2023/09/01 16:54:32

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Basic information

Public title

Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

Acronym

Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

Scientific Title

Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

Scientific Title:Acronym

Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

Region

Japan


Condition

Condition

Colorectal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate efficacy and safety of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatn-based chemoterapy without CV port.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Disease control rate
Progression free survival
Overall survival
Safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Irinotecan plus S-1 (IRSI) with biweekly cetuximab combination therapy
1)Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD
2)S-1 80mg [BSA<1.25m2] or 100mg [1.25m2<BSA<1.5m2] or 120mg [1.5m2<BSA]/body/day, day 1-14, q4weeks
3)Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed colorectal cancer.
2) Clinically proven unresectable advanced / metastatic colorectal cancer
3) Previously received on one regimen of oxaliplatin-contained chemotherapy (contained relapse less than 6 months from adjuvant chemotherapy)
4) Presence of at least one measurable lesion (according to the RECIST ver.1.1)
5) Immunohistochemical evidence of EGFR expression, either in the primary tumor or in metastatic tumor lesion
6) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion
7) Patients unaffected prior therapy
At least 4-6 weeks since prior radiotherapy
At least 4 weeks since prior operation for organ
At least 2 weeks since prior chemotherapy
At least 2 weeks since prior immune therapy, cytokine therapy or BRM therapy
8) More than 20 years of age
9) ECOG performance status 0-1
10) Adequate organ function for study treatment
WBC>=3,000mm3, neutrophils>=1,000/mm3
Platelets>=100,000/mm3
Hemoglobin>=9.0g/dl
AST and ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis)
Total bilirubin<=upper limit of normal (ULN)*2
Creatinine<=1.5mg/dl
11) Oral food intake possible
12) Life expectancy must be 3 months or longer after the combination therapy
13) Written informed consen+C120t

Key exclusion criteria

1) History of severe allergy
2) Simultaneous or metachronous double cancers
3) Symptomatic brain metastasis
4) Severe infectious disease
5) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice)
6) Paralytic or mechanical bowel obstruction
7) Massive pleural effusion or ascites
8) Wattery diarrhea
9) Patients who is receiving Atazanavir Sulfate or Flucytosine
10) Pregnant or lactating women or women of childbearing potential
11) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoichiro Yoshida

Organization

Fukuoka University Faculty of Medicine

Division name

Department of Gastroenterological Surgery

Zip code


Address

7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoichiro Yoshida

Organization

Fukuoka University Faculty of Medicine

Division name

Gastroenterological Surgery

Zip code


Address

7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Fukuoka Tumor Research(FUTURE)

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

福岡大学医学部消化器外科学


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2011 Year 06 Month 28 Day

Date of IRB

2011 Year 11 Month 15 Day

Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 12 Month 03 Day

Last modified on

2023 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008068


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name